510(k) · Cleared
Recalled · 2007Xpert, Genexpert DX System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cepheid · NJR Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test
Cleared on Jul 25, 2006 as substantially equivalent to K022504 (Infectio Diagnostic, Inc., 2002) after a 146-day review. Its family tree reaches back 3 generations to 1994. 1 later device descends from it. It has been recalled once.
- Decided
- Jul 25, 2006
- Review
- 146 days
- Class
- Class I
- Product code
- NJR
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 3 generations to K936112 (1994). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK936112 Strep B OiaBiostar, Inc. · 1994
- 2 generations backK991828 Strep B OiaBiostar, Inc. · 1999
- 1 generation backK022504 Idi-Strep B AssayInfectio Diagnostic, Inc. · 2002
- This deviceK060540 Xpert, Genexpert DX SystemCepheid · 2006
- Descendant · cites it directly · 0 of its ownK222638 Xpert® Xpress GBS, GeneXpert® Dx System, GeneXpert® Infinity SystemsCepheid · 2023
Most influential descendants
Showing 1 of 1 · See all- K222638Xpert® Xpress GBS, GeneXpert® Dx System, GeneXpert® Infinity SystemsCepheid · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K936112 | Strep B Oia | Biostar, Inc. | 1994 | — |
| −2 | K991828 | Strep B Oia | Biostar, Inc. | 1999 | — |
| −1 | K022504 | Idi-Strep B Assay | Infectio Diagnostic, Inc. | 2002 | — |
| 0 (this device) | K060540 | Xpert, Genexpert DX System | Cepheid | 2006 | — |
| +1 | K222638 | Xpert® Xpress GBS, GeneXpert® Dx System, GeneXpert® Infinity Systems | Cepheid | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NJR? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new NJR device
- #1 K222638 Xpert® Xpress GBS, GeneXpert® Dx System…score 7.0 · 4 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K022504 | Idi-Strep B AssaySummary page 1…code: NJR Classification Microbiology Advisory Committee: Predicate Device: IDI-Strep B'Tm Assay [5 10(k) no. K022504] Device Description: The Xpert GBSTM is a rapid, fully-automated DNA test for detecting GBS directly from vaginal/rectal swab spe… | 2002 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K222638 | Xpert® Xpress GBS, GeneXpert® Dx System, GeneXpert® Infinity Systems | 2023 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 5, 2007 | Not classified | Z-0376-2008 | Release of Material/Component prior to receiving test results | Labeling Error: Some cartridges may be mislabeled as "Xpert EV" instead of "Xpert GBS". (The information embedded in the barcode label on the cartridge is correct for Xpert GBS and brings up the GBS assay definition file) |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 3.7 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K222638 (Cepheid, 2023) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K022504.
How does its category compare?
All NJR devicesNJR Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NJR
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · NJR
87in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NJR
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NJR
14in 2024
MAUDE reports naming product code NJR, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 1 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 1 | — | 1 | 0 |
| 2012 | 3 | 162 | 2 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 1 |
| 2015 | 1 | — | 1 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 2 | — | 0 | 1 |
| 2018 | 3 | 87 | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 1 | — | 1 | 3 |
| 2023 | 1 | — | 0 | 8 |
| 2024 | 0 | — | 2 | 14 |
| 2025 | 0 | — | 1 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Cepheid Xpert GBS performed on the GeneXpert Dx System is a qualitative in vitro diagnostic test designed to detect Group B Streptococcus (GBS) DNA from vaginal/rectal swab specimens, using fully automated real-time polymerase chain reaction (PCR) with fluorogenic detection of the amplified DNA. Xpert GBS Assay testing is indicated for rapid identification of antepartum and intrapartum GBS colonization. * The use of the Xpert GBS for intrapartum…
Read the full statement (126 words)
The Cepheid Xpert GBS performed on the GeneXpert Dx System is a qualitative in vitro diagnostic test designed to detect Group B Streptococcus (GBS) DNA from vaginal/rectal swab specimens, using fully automated real-time polymerase chain reaction (PCR) with fluorogenic detection of the amplified DNA. Xpert GBS Assay testing is indicated for rapid identification of antepartum and intrapartum GBS colonization.
* The use of the Xpert GBS for intrapartum screening should not preclude the use of other strategies (e.g., antepartum testing). Intrapartum Xpert GBS results are useful to identify candidates for intrapartum antibiotic prophylaxis when administration of intravenous antibiotics is not delayed pending results.
* The Xpert GBS assay does not provide susceptibility results. Culture isolates are needed for performing susceptibility testing as recommended for penicillin-allergic women.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060540 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060540: Xpert, Genexpert DX System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060540
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026